In the human body, iron is essential for the implementation and maintenance of several vital cellular functions and biosynthetic processes, including oxygen transport capabilities, aerobic cellular activity, intracellular electron transport, and integral enzymatic reactions within body tissue. Unfortunately, as a combined result of various socioeconomic conditions, environmental factors, genetic predispositions, and the collective dietary habits amongst the general populace, iron deficiency is the most common known form of nutritional deficiency amongst humans.
Of significant prevalence, especially amongst children and women (i.e., particularly pregnant women and/or women of childbearing age), is iron deficiency anemia, a condition defined by a gross reduction in overall iron levels in the red blood cells and, thus, a decline in hemoglobin synthesis, the molecule ultimately responsible for the transport and distribution of oxygen from the lungs to tissues of the body. Indeed, in pregnant women, iron deficiency increases both the risk of pre-term delivery and/or delivery of a low-birthweight baby, whereas with children, iron deficiency anemia may cause developmental delays, behavioral disturbances, altered growth patterns, and increased infections. Still other manifestations symptomatic of iron deficiency anemia may include pale skin tone or color, headaches, extreme fatigue, light-headedness, glossitis (swelling of the tongue), koilonychias (spoon nails), and other overt, albeit extreme, behavioral disturbances, such as the consumption of dirt or clay (pica or geophagia), or the abnormal consumption of ice (pagophagia).
Accordingly, the maintenance, or bioavailability, of nutritionally adequate iron levels is largely a collective function of the composition of food consumed, the quantity and chemical form of iron contained therein, and the presence of food items that either promote or inhibit iron absorption. Specifically, iron is absorbed as either a heme iron (an intact metalloporphyrin ring), or nonheme iron (ionic iron). Heme iron, however, which is principally found in meat as hemoglobin or myoglobin, is more readily and effectively absorbed than nonheme iron and, thus, provides a significantly greater dietary source of iron than nonheme iron. Additionally, food items such as bran, wheat, soy and other cellulosic products, which seemingly have no influence on heme iron absorption, tend to appreciably inhibit nonheme iron absorption; thus, exposing vegetarians to a relatively greater risk of developing an iron deficiency.
In fact, as professed by the American Society for Clinical Nutrition, approximately 5%-35% of heme iron is absorbed from a single meal, whereas nonheme iron absorption from a single meal can range from approximately 2% to 20%, depending on the iron status of the individual and the ratio of enhancers and promoters in the diet. Accordingly, although heme iron constitutes only approximately 10% of dietary iron intake, heme iron may provide up to one-third of overall absorbed dietary iron. Consequently, inadequate consumption of foods high in heme iron content, especially during periods of increased iron demand (i.e., gestational and/or lactational periods), deprives the body of a considerable percentage of necessary dietary iron. Unfortunately, whether due to staunch dietary habits or beliefs, or the unavailability of certain foods due to prevailing socioeconomic and/or geographic conditions, the consumption of foods low or deficient in heme iron content, or the strict consumption of nonheme iron foods, will likely result in iron deficiency anemia.
Accordingly, as an alternative to radical dietary adjustment, iron supplements have traditionally offered a more subtle, therapeutic approach to the treatment of iron deficiency. However, the efficacy of supplement intervention (i.e., total effective iron absorption) is dependent upon a number of factors, the most of germane of which is the composition of the supplement and the total iron dosage.
That is, various iron supplements are typically prescribed in doses containing between 40 mg and 150 mg of elemental iron per day, wherein a higher dosage of iron results in greater overall absorption. However, a high dose of iron as a dietary supplement (or fortificant) is not without consequence. Indeed, many existing iron supplements cause distressing side effects, such as nausea, diarrhea, constipation and/or cramping; thus, resulting in patient non-compliance with the prescribed supplement regimen. Further, it has been strongly suggested that high single doses of iron may contribute to the elevated formation of highly reactive oxygen radicals and, thus, promote various pathogenic processes, such as cardiovascular disease.
Still other clinically-administered iron supplement preparations that contain iron salts, such as ferrous sulfate, (hydrated) ferrous gluconate, or ferrous fumarate, as the primary iron source, may actually provide less iron than otherwise expected. Specifically, although inconsequential to heme iron absorption, dietary supplementation with such ferrous salts effectively reduces nonheme iron absorption and, thus, offers a counter-intuitive approach to individuals whose already limited iron intakes are dependent upon a diet high in nonheme iron content (i.e., vegetarians, indigents, etc.).
Therefore, it is readily apparent that there is a need for a composition and method for treating iron deficiency anemia, wherein the composition accounts for dietary inconsistencies across the broad spectrum of patient demographic, and further reduces, if not eliminates, the side effects associated with traditional iron supplements; thereby, increasing overall patient compliance. Accordingly, the composition of the present invention proffers such results through the combination of heme iron and/or heme iron polypeptide with ionic irons (i.e., iron salts) and/or chelated irons, wherein the combination provides a synergistic effect that substantially reduces the prescribed iron dosage, yet significantly increases overall iron absorption. There is a further need for such a composition that offers additional vitamins and minerals in conjunction with the prescribed iron content.